Bone repair system and method

ABSTRACT

A bone repair system and method for percutaneously fixing a first bone segment to a second bone segment, such as rib bone segments, in a body of a patient include drilling a first hole through the first bone segment and a second hole through the second bone segment, and feeding a first tether through the first hole and a second tether through the second hole, each tether having a proximal end and a distal end. The first and second tether distal ends are withdrawn from the body while the first and second tether proximal ends have not passed through the first and second bone segments, respectively. A reinforcing member, such as a bone plate, having first and second openings, is passed onto the first and second tether distal ends, and the reinforcing member is pulled into engagement with the first and second bone segments guided by the tethers. The reinforcing member is secured to the first bone segment with a first fastener assembly through the first hole and the first opening and to the second bone segment with a second fastener assembly through the second hole and the second opening to fix the first bone segment to the second bone segment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/252,064 filed Apr. 14, 2014, which is a divisional of U.S.application Ser. No. 12/825,967 filed Jun. 29, 2010, now U.S. Pat. No.8,728,133, which claims the benefit of U.S. provisional Application No.61/221,744 filed Jun. 30, 2009 and U.S. provisional Application No.61/314,865 filed Mar. 17, 2010, the disclosures of which areincorporated in their entirety by reference herein.

TECHNICAL FIELD

This invention relates to a system and method for the repair offractured or broken bones, such as ribs.

BACKGROUND

A flail chest is a condition that occurs when multiple adjacent ribs arebroken, separating a segment of the chest wall so that it becomesdetached from the rest of the chest wall and moves independentlytherefrom. This detached segment moves in the opposite direction as therest of the chest wall, moving inward while the rest of the chest ismoving outward and vice versa, creating “paradoxical motion” thatincreases the effort and pain involved in breathing.

Most rib fractures are treated conservatively using pain managementand/or bracing techniques. Fractured ribs in a flail chest treated insuch a manner may undergo progressive displacement during the healingphase, resulting in considerable deformity, volume loss, atelectasis,and chronic pain. Long-term problems of patients with flail chestinjuries treated nonoperatively include subjective chest tightness,thoracic cage pain, and dyspnea.

Four categories of fixation devices for operative chest wall fixationhave been utilized, namely plates, intramedullary devices, verticalbridging, and wiring. The results of these repair techniques are oftenless than desirable because of the difficulty in correctly locating thebroken rib ends with one another. Stabilizing rib fractures ischallenging because large incisions are typically needed to accommodatefixation, which leads to a more morbid procedure. In addition, ribs arenarrow with a thin cortex that surrounds soft marrow, making reliablefixation problematic under conditions that include upwards of 25,000breathing cycles per day, as well as coughing. Still further, there isrisk of damage to the neurovascular bundle.

Currently, the surgery involves a significant operative procedure withmobilization of large chest wall flaps or open thoracotomy. The problemsand risks of an operative approach include the surgical trauma itselfand the loosening and migration of implants. The surgery involves amajor incision through the muscle directly down to the ribs, which canhave complications such as loss of muscle function, blood loss, anddamage to surrounding vascular and neural tissue. The ribs that are tobe fixed need to be adequately exposed in order to obtain a goodplacement of metal fixation plates. A wide incision is performed, andmyocutaneous flaps may need to be raised to allow visualization of allsegments. Posterior injuries are usually challenging due to the presenceand required exposure of large muscle fibers (e.g., latissimus dorsi,trapezius, rhomboids, paraspinous muscles). The procedure utilized incurrent practice is typically at least three hours in length with anadditional hour required for the closing of the surgical exposure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a trocar in accordance with an aspect ofthe present invention;

FIG. 2 is a schematic representation of the trocar engaged with apatient's rib;

FIG. 3 is a top plan view of a bone plate in accordance with an aspectof the present invention;

FIG. 4 is a top plan view of an outer fastener in accordance with anaspect of the present invention;

FIG. 5 is a side elevational view of a fastener assembly in accordancewith an aspect of the present invention with a cable passedtherethrough;

FIG. 6 is a side elevational view of an outer fastener, trocar, anddrive tool in accordance with an aspect of the present invention with acable passed therethrough;

FIG. 7 is a side elevational view of a bone plate and inner fastenercombined with the components of FIG. 6;

FIG. 8 is a schematic representation of an alternative fastener assemblyaccording to an aspect of the present invention;

FIG. 9 is a side elevational view of a fastener assembly and drive toolaccording to another aspect of the present invention with a flexible rodpassed therethrough;

FIG. 10 is a side elevational view of the drive tool engaged with theouter fastener;

FIG. 11 is a side elevational view of the engaged outer and innerfasteners and the flexible rod and drive tool removed;

FIG. 12 is a schematic representation of a trocar in accordance with thepresent invention engaged with a patient's rib;

FIG. 13 is a schematic representation of a drill guide inserted into thetrocar;

FIG. 14 is a schematic representation of rods passed through the trocarand newly formed holes in the rib;

FIG. 15 is a schematic representation of a rod being passed through therib and back out of the chest cavity;

FIG. 16 is a schematic representation of the drive tool inserted intothe trocar and the inner fastener and bone plate being passed throughthe opposite ends of the rods into engagement with the internal surfaceof the rib;

FIG. 17 is a schematic representation of the inner fastener and boneplate being secured into position on the rib via tightening of the outerfastener with the drive tool;

FIG. 18 is a schematic representation of the bone plate secured inposition on the internal surface of the rib;

FIG. 19 is a top plan view of a surgical kit in accordance with anaspect of the present invention;

FIG. 20 is a perspective view of a deformable plate component accordingto an aspect of the present invention being inserted through the rib ina rolled configuration;

FIG. 21 is a side cross-sectional view of a deformable plate componentinserted through and between two adjacent holes in the rib;

FIG. 22 is a top plan view of a deformable plate component in a deployedconfiguration in accordance with an aspect of the present invention;

FIG. 23 is an illustration of a composite reinforcing structuralcomponent or patch disposed across a plurality of ribs according to anaspect of the present invention;

FIG. 24 is a side elevational view of a patch engaging a rib withassistance from a pressure applying device such as a balloon inaccordance with an aspect of the present invention;

FIGS. 25a and 25b are schematic representations of a fastener in a firstposition for insertion and second position for deployment, respectively,in accordance with an aspect of the present invention;

FIG. 26 illustrates a fastener engaging a reinforcing member accordingto an aspect of the present invention;

FIG. 27 illustrates another fastener engaging another reinforcing memberaccording to an aspect of the present invention; and

FIG. 28 depicts a bone plate with legs for receiving the fastenertherebetween in accordance with another aspect of the present invention.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention.

The present invention provides a system and method for repairingfractured or broken bones, such as ribs. The system and method accordingto the present invention allow bone repair to be performed in aminimally invasive manner, thereby lessening patient recovery time.Although the system and method are shown and described herein as beingapplied to the repair of fractured ribs, it is understood that theirapplication to the repair of other broken bones is fully contemplated.For example, the system and method according to the present inventionmay also be utilized for the minimally invasive repair of bone segmentssuch as a fractured clavicle, fractured tibia, fractured pelvis,fractured spine, or fractured joint surface where there are displacedand/or multiple bone fragments that would otherwise require a large opensurgical exposure to repair.

In overview, in accordance with an aspect of the present invention,fixation of bone segments such as fractured ribs includes the placementof tethered repair components through a percutaneous skin incision downto the bone and delivery of repair components into the pleural space.Assistance may be provided by a video-thorascope, imaging technologies,or other minimally invasive observation method. The tethered repaircomponents include a reinforcing member, such as a bone plate, and afastener assembly, such as a screw and nut or other compressive fastenerassembly, wherein the broken rib segment is stabilized by securing thebone plate against the rib with the fastener assembly. The bone platemay be attached to the rib on its internal surface, the side of the riblining the pleural space. The tether, such as a cable or rod, serves tofacilitate the procedure by guiding and providing control over therepair components, and to provide safety and efficiency for the surgeon.

The use of such means of rib fixation according to the present inventionallows for the passage of fastener hardware through the central,thickest portion of the rib, thus minimizing the risk of inadvertentdamage to the peripheral neurovascular anatomy. Further, the rib is avery small bone that typically has only a thin cortical shell or, insome cases, is comprised of largely cartilaginous material. Thus, atraditional repair utilizing typical bone screws has a significantchance of the screw loosening and thus the plate becoming loose overtime.

A rib fracture repair can be performed in accordance with an aspect ofthe present invention utilizing one or more small (e.g., <15 mm)percutaneous incisions. A first incision may be utilized topercutaneously locate and drill holes for the passage of fasteners whichallow for simultaneous capture and engagement with both inner and outerportions of the rib and mechanical interlock with the reinforcingmember. A second incision allows for the percutaneous insertion offasteners and reinforcing members to be placed against the rib via thepleural space. A third incision may be utilized to allow for thorascopicvisualization of the fracture site. In the drawings provided herein,although not shown, it is understood that the patient's skin overliesthe ribs R and the above-described incisions are made therethrough.

With reference to FIGS. 1 and 2, in accordance with an aspect of thepresent invention, a trocar 10 may be percutaneously inserted through askin incision (i.e., the first incision described above; not shown) andplaced in contact with the rib R. Insertion of the trocar 10 assists inlocating the rib R and is used to facilitate drilling of a hole throughthe rib R for affixing the reinforcing member to the rib R. The trocar10 may be generally tubular or have an otherwise hollow configuration,and have a length capable of reaching the affected fracture site andengaging the bone in a controlled fashion. The trocar 10 may include twospaced spades or protrusions 12 at the engagement end 14 thereof to helporient the trocar 10 relative to the affected bone. The protrusions 12may orient the trocar 10 centrally over a width of the rib R or in amanner such that another specific location on the bone and the longorientation of the bone can be positively identified by the surgeon.Further, the protrusions 12 may actively engage the bone in such amanner as to cause a positive lock to the bone, thus maintaining theposition of the trocar 10 relative to the bone and fracture sitethroughout the surgery. In one embodiment, the protrusions 12 may bediametrically spaced on the trocar engagement end 14.

During the surgical repair, the protrusions 12 may be positioned alongthe sides of the rib R as illustrated in FIG. 2, thus generallycentering the trocar 10 over the rib R. Accordingly, the trocar 10 willlocate a subsequently inserted drill guide generally centrally over thewidth of the rib R such that the hole drilled for receipt of thefastener assembly will be generally located in the center of the rib Ras measured from side to side. According to an aspect of the presentinvention, a navigated trocar may be employed.

Turning to FIG. 3, an exemplary reinforcing member, bone plate 16, isdepicted which may be constructed from an appropriate material such as,but not limited to, titanium, stainless steel, polymer, ceramic or abio-resorbable material or combinations thereof. The bone plate 16includes at least two openings to accept a fastener assembly that allowsthe bone plate 16 to be securely fastened in position. In oneembodiment, the bone plate 16 includes a hole 18 at one end at least oneelongated slot 20 at the other end. In accordance with an aspect of thepresent invention, the hole 18 may either be square or have anothernot-round shape. The bone plate 16 can be constructed with anycombination of holes 18 and elongated slots 20 for achieving the desiredstability. With reference to FIG. 18, a non-limiting example includes asingle hole 18 and three elongated slots 20. Providing a bone plate 16with one or more elongated slots 20 allows the hole locations in thebone to be more flexible along each slot 20 for bone plate location,thus less precision is required. This is especially beneficial whenpositioning a bone plate 16 along the more curved elements of the ribs.

For the type of repair described herein, according to one non-limitingaspect of the present invention, the bone plate 16 may be approximately2-20 mm in width, or more particularly 8-12 mm in width. The length ofthe bone plate 16 is as needed, but according to one non-limiting aspectof the present invention may range from 40-400 mm. The thickness of thebone plate 16 can be uniform or variable, such as providing greaterthickness near the middle of the bone plate 16 to enhance stiffness orto tailor the stiffness to a specific level, such as to match theparticular section of the rib bone. According to one non-limiting aspectof the present invention, bone plate thickness may range from 0.25-4 mm.The bone plate 16 may be generally linear or may include angled portions(FIG. 19). Of course, it is understood that the bone plates 16 describedherein may have any shape and are not limited to any of the abovedimensions, and may instead appear as cables, rods, or other shapes.

The bone plate 16 may be generally planar, or may instead be curved(FIG. 19). The bone plate 16 can be curved in a planar fashion ortwisted in a non-planar, curvilinear fashion in order to conform to themore difficult shapes of certain ribs, such as those found in the mostanterior and posterior portions of the rib cage. Curvature desired ofthe bone plate 16 can be based on CT or other noninvasive diagnosticimaging techniques, or through physical measurement of the rib cage atthe time of surgery. Curvature in the bone plate 16 can be establishedat the time of manufacture, thus providing a library of shapesappropriate to the approximate shape(s) of the rib(s) to be repaired, orthe bone plate 16 could be custom bent at the time of the surgery in theoperating room.

In one embodiment, a CT of the patient's rib cage may be performed priorto surgery. The CT data may then be fed into a specially designedanalytical software program, wherein the ideal shape of the bone plate16 may be determined based on the shape of the existing healthy portionsof the patient's rib cage and anatomical atlases. A determination may bemade, with a combination of this analytical software and surgeon input,to establish the ideal shape of the bone plate 16 required to repair thefracture site. A computer-controlled bending or template machine can beutilized to mold or shape an existing generically sized bone plate 16into a specific patient-matched plate, prior to or at the time of thesurgery, thereby minimizing the time required to complete the surgicalrepair.

According to an aspect of the present invention, the bone plate 16 canbe coated with a substance to assist in reducing inflammation. Accordingto another aspect of the present invention, an adhesive may be appliedto the bone plate 16 to adhere it permanently or temporarily to the rib.

With reference to FIGS. 4 and 5, first, or outer 22, and second, orinner 24, fasteners according to an aspect of the present invention areshown, wherein the outer and inner fasteners 22, 24 each include alongitudinal channel (not shown) in order to receive a tether, such as acable or rod, therethrough. Outer and inner fasteners 22, 24 engage toform a fastener assembly that secures the bone plate 16 to the rib. Inone embodiment, the outer fastener 22 may be a threaded screw and theinner fastener 24 may be a nut, although it is understood that otherfasteners are also contemplated. For example, fasteners such as screwswith machine threads, tapered threads, rivets, adhesively joined, andother such positive engagement type fasteners may be utilized.

The inner fastener 24, which resides in the pleural space, may have aportion, such as shoulder 26, shaped to facilitate engagement with andprevent rotation of the fastener assembly when engaging the holes 18 orslots 20 of the bone plate 16. In one embodiment, a square or othernon-round shaped shoulder 26 may be used. Such a configuration isbeneficial since the surgeon may not have direct physical access to theinner fastener 24 in order to hold the inner fastener 24 securely whiletightening the outer fastener 22 as described below. The inner fastener24 may also be engaged mechanically to the bone plate 16 prior to itsinsertion. The outer fastener 22 may include an engagement port 28 forengagement by a drive tool 30 (FIG. 6) to accomplish tightening of theengaged fastener assembly. Of course, it is also contemplated that adrive tool could be configured to be inserted into the pleural space andengage with and tighten the inner fastener 24, or that the outerfastener 22 could include a shoulder as described above.

As shown in FIGS. 5-7, each of the fastener assembly 22, 24, the trocar10, the drive tool 30, and the bone plate 16 are configured to have atether or guide member, such as a cable 32, passed therethrough, whereinthe cable 32 also passes through a hole drilled in the bone in order tolocate and guide the bone plate 16 and fasteners 22, 24. In oneembodiment, each cable 32 or other tether may be colored or have anotheridentifying feature, and may include a secure grommet 34 at its proximal33 and distal 35 ends to maintain control of the location of the repaircomponents.

Instead of a cable 32, a flexible rod 36, such as made of plastic ormetal, may be used as depicted in FIGS. 9-11. The rod 36 may be used topass through inner and outer fasteners 22, 24 and the drive tool 30 asshown in FIG. 9, along with passing through the other components and thedrilled bone, performing a guide function for the repair components aswith the cable 32 described above. Rod 36 includes proximal 37 anddistal 39 ends, wherein a distal end 39 of the rod 36 may be threaded orutilize other mechanical means for securing the inner fastener 24thereto. Of course, it is understood that grommets 34 could be insteadused with the rods 36, and that the cable distal end 35 could instead bethreaded. Along the flexible rod 36, the drive tool 30 engages the outerfastener 22 (FIG. 10) and tightens it to the inner fastener 24 (FIG.11). If further safety is desired, the rod 36 can also be made hollow toaccept a centrally located wire or cable in case the rod 36 fails. Useof a larger diameter flexible rod 36, as compared with a cable 32, mayallow the surgeon to exert more tensile force on the bone plate 16 andfastener assembly 22, 24 without undo risk of breakage. A portion of therod 36 may also be used as an integral portion of the final fastenerassembly.

In another embodiment, a snare-type tether may be used that can loop orotherwise engage the reinforcing member 16 to facilitate locating thereinforcing member 16 against the rib. Such a snare-type tether can alsoact as both as a fastener and guidance mechanism, such that it iscontemplated that the inner fastener 24 could be eliminated. Inaddition, the tether distal end may mechanically engage the reinforcingmember 16 for pulling the reinforcing member 16 into the body andsecuring to a fastener, such as with a bayonet connection.

In accordance with another aspect of the present invention, analternative to the threaded fastener assembly is the use of an innerfastener comprising a grooved member 38, inserted through the bone fromthe inside as depicted in FIG. 8. While under location and tensilecontrol by the cable 32 or rod 36, an outer fastener comprising a rapidconnecting ratcheting nut 40 may be pushed down over the grooved member38. In this embodiment, the nut motion is only vertical relative to thebone plate 16, thus measures for preventing fastener rotation areunnecessary. The underside of the nut 40 may have a concave shape suchthat it has a more intimate fit with the outer surface of the rib andcan distribute the compressive loads of the nut 40 more evenly to therib.

In a further variation, a fastener assembly may be utilized that isadhesively bonded together while under compressive loading, applied froma tool capable of pulling the inner fastener 24 and bone plate 16together with the outer fastener 22. While holding the assembly underthe compressive loading, thus securing the bone plate 16 to the rib, anadhesive may be applied either alongside the cable 32 or from within ahollow core of the rod 36. Once the adhesive is set, the cable 32 or rod36 can be removed, provided they are coated with a release or non-stickcoating. If such a coating is not provided, the cable 32 or rod 36 canbe cut off, such as near the top of the outer fastener 22.

Simultaneous with the adhesive approach, or in combination with theall-mechanical approach of the fastener assembly, the hollow rod 36 orfastener assembly 22, 24 could be used to deliver bone cement to thefracture site while the fracture is in a reduced state. The fastenerassembly could be removed upon setting of the bone cement or be left inplace. If the fastener assembly is made of bio-resorbable materials, thefastener assembly could be left in place to resorb over a period oftime, ultimately leaving no sign of the original fracture repair.

With reference now to FIGS. 12-18, a method for repair of a bonefracture F in accordance with the present invention will be describedwherein a first bone segment 1 is fixed to a second bone segment 2. Thefracture site to be repaired may be initially identifiedradiographically or via ultrasound and, at the time of surgery, throughvideo-assisted viewing through a thorascope (not shown). The site may bepalpated externally and confirmed internally to identify the size andlocation of the fracture and any displacement of the rib segments. Apercutaneous incision (e.g., the first incision described above) may bemade directly over an intact, stable portion of the rib followed with ablunt dissection of the tissue down to the bone itself. As shown in FIG.12, according to an aspect of the present invention, the trocar 10 maybe used to locate the rib R by passing the trocar 10 through the softtissue down to the bone. The trocar 10 may be positioned generallycentrally over the rib by assuring that the protrusions 12 arepositioned along the sides of the rib R. The trocar 10 may also activelyengage the bone in such a manner as to cause a positive lock to thebone, thus maintaining the position of the trocar relative to the boneand fracture site throughout the surgery.

Referring to FIG. 13, according to an aspect of the present invention, adrill guide 42 may be placed inside the trocar 10 and used to facilitatethe drilling of a hole through the bone, wherein the hole will receivethe fastener assembly 22, 24. In one embodiment, a drill, such as acannulated wire drill, may be used to facilitate passage of the cable 32or flexible rod 36 through the rib R to the other side of the fracturedbone. In some situations, the rod 36 or cable 32 may be passed throughthe drilled hole on its own after removal of the drill. Drilling mayoccur under direct visualization using a thorascope. Furthermore,utilization of fluoroscopy or another real-time imaging method may aidthe surgeon in locating, repositioning and fixing in place the displacedrib segments.

As shown in FIG. 14, according to an aspect of the present invention,the rod 36 (or cable 32 or other tether) is passed through the drillguide 42, and through the created hole in the rib R and into the pleuralspace. A first rod 36 and a second rod 36′ are depicted. The entranceinto the pleural space may be visualized with a video thorascope. Thecable or rod distal end 35, 39 is grabbed, such as with a graspinginstrument (not shown), and withdrawn through the second incisionreferenced above and outside of the chest cavity (FIG. 15). As analternative, the threaded rod or cable may be externally guided suchthat its placement and path through the pleural space can be entirelyguided by the surgeon without the need for thorascopic instruments tograb them from the inside, similar to the manner in which an endoscopeis manipulated. This externally guided rod or cable assembly can alsohave the video guidance built into it, thus eliminating any need for athorascopic incision port (i.e., the third incision referenced above).At this point in the surgery, both the proximal 33, 37 and distal 35, 39ends of the cable 32 or rod 36 are visible from outside of the patient'sbody.

Once inserted through the rib, both the cable 32 and the threaded rod 36can also be used to reduce the fracture through mechanical manipulationof the bone ends. The surgeon is able to pull on the displaced bonedirectly from outside of the chest cavity without the need for a largerexposure while simultaneously aligning the bone plate 16 and fasteners22, 24 into final position. While applying such correcting force, thesurgeon is able to tighten or otherwise fasten the bone plate 16 intoits final corrective position. Since the method according to the presentinvention allows for access to both sides of the rib simultaneously, incertain circumstances it may also be desirable to pass a tether, such asa cable, from one drilled rib hole to another in order to pull the bonestogether. In this instance, a grommet or other stop can be placed on theproximal or distal end of the tether to prevent the tether from pullingthrough the holes when force is applied to the end of the tetheropposite the stop.

FIG. 16 illustrates placement of the bone plate 16 and first and secondinner fasteners 24, 24′ onto the first and second flexible rods 36, 36′,respectively, in accordance with an aspect of the present invention.When a cable 32 is used, once the cable 32 is drawn through theabdominal wall, the bone plate 16 may first be passed over the cabledistal end 35 followed by the inner fastener 24. A grommet 34 (or a wirebutton or the like) may be used to secure the distal end 35, wherein thegrommet 34 should be large enough to prevent the bone plate 16 and innerfastener 24 from becoming disengaged from the cable 32. When a rod 36 isused, once the rod 36 is drawn through the abdominal wall, the boneplate 16 may first be passed over the rod distal end 39. The innerfastener 24 may then be threaded or otherwise secured onto the distalend 39 for positive control over the bone plate 16 and fastenerassembly. Once the repair components have been secured to the cable 32or rod 36, the components are ready to be drawn back into the thoraciccavity for placement against the desired rib segment pulled and guidedby the cable 32/rod 36.

The procedure may be repeated for subsequent drilled holes, typically onthe other side of the bone fracture F, wherein a differentlyidentifiable (e.g., color or other means of identification) cable 32 orrod 36 may be used in order to identify the particular location throughthe rib R. As described above, the bone plate 16 may include one or moreelongated slots 20 through which additional cables 32/rods 36 may bepassed. An initial distance measurement between drilled points on thebone may be made of the external (e.g., first) incision points. Thatdistance may be further confirmed by the use of a thorascopicallydeployed measuring instrument so that the inner distance between holescan be made. This measurement provides information as to the curvilinearand/or straight configuration of the rib cage, and provides the surgeonwith an accurate assessment of the relative drilled bone position oncethe fracture site has been properly reduced. The use of a combination ofholes 18 and slots 20 on the bone plate 16 reduces the need for exacthole placement on the rib by the surgeon, as the final position of thefasteners 22, 24 on the bone plate 16 is adjustable due to use of theslots 20. This configuration accommodates imprecise drilled hole andfastener placement through the rib.

Once the desired number of cables 32/rods 36 has been brought outthrough the instrument port (e.g., second incision), the bone plate 16may be fed onto the cables 32/rods 36 in the proper orientation. In oneembodiment, the end of the bone plate 16 where the single square hole 18is located may be utilized against the stable rib portion. The boneplate 16 and inner fastener 24 may then be drawn into the chest cavityand pleural space and, with possible video and thorascopic assistance,the bone plate 16 may be positioned near the site of the rib fracture tobe repaired while the cables 32/rods 36 are slowly drawn through thedrilled holes in the rib R as illustrated in FIG. 17. The use of two ormore cable or rod assemblies at one time will assure the properorientation of the plate and fastener assemblies once pulled back intoand against the internal surface of the chest cavity.

In accordance with an aspect of the present invention, once the drillguide 42 is removed from the trocar 10, the outer fastener 22 may bemoved into position along the cable 32/rod 36 through the drilled holeinto the bone, into engagement with the inner fastener 24, and securedthereto with the drive tool 30 (FIG. 18). In one embodiment, thefastener assembly 22, 24 inserted through the hole 18 of the bone plate16 may be tightened first, followed by the fastener assembly 22, 24inserted through the slot 20 since less alignment between the rib holeand bone plate opening is required with the slot configuration. Tensionmay be applied to the cable 32/rod 36 by the surgeon, thus drawing theinner fastener 24 into position with the bone. Once the inner fastener24 engages the bone plate 16, the outer fastener 22 may be tightenedwith the drive tool 30 until the desired level of torque and tightnesshas been reached. The drive tool 30 may engage the engagement port 28 ofthe outer fastener 22 in order to rotate the outer fastener 22 andsecure it to the inner fastener 24. In one embodiment, the innerfastener 24 may be prevented from turning by its square shoulder 26engaging in a square hole 18 on the bone plate 16. Of course, othermethods of securing the outer and inner fasteners 22, 24 together arealso fully contemplated.

In one embodiment, a washer (not shown) may be used under the outerfastener 22 to aid in distributing the load between the outer fastener22 and the bone. The washer may be concave shaped (on the bone-matingside), oriented to fit saddle-like over the rib, to attempt to furtherreduce localized stresses on the bone. The washer may also be enhancedwith a deformable component to reduce the localized bone stresses evenfurther.

If repositioning of the rib segment is required to reduce the fracture,then the use of a device, such as a gimlet, can be used to helpfacilitate the relocation of the broken segment while the fastenerassemblies 22, 24 are tightened. The cable 32 or rod 36 can also can actto facilitate alignment of bone segments for reduction of the fracturesite, since the bone segment can be pulled with the cable 32 or rod 36and re-located as required once the inner fastener 24 and the bone plate16 are engaged with the inner side of the bone. In addition to the useof the cable 32 or rod 36 to facilitate reduction of the fracture site,a pressure applying device, such as a balloon, can be used as part ofthe thorascope assembly or in conjunction with it to apply pressureagainst the pleura, and thus the ribs, and position them into aconforming shape. This will help reduce the fractured ribs if necessary,and hold the ribs in that position until the fasteners 22, 24 aretightened.

Once all of the fastener assemblies 22, 24 are tightened and the surgeonis comfortable with the location, tightness, stability and otherparameters such as reduced position of the bones, the rod 36 may beunscrewed or otherwise detached from the inner fastener 24 and removed,thus completing the repair. In the case of the cable 32, the grommet 34on either end 33, 35 may be cut and the cable 32 withdrawn from thechest cavity. Standard layer closure utilizing resorbable suturesfollowed by a local rib block (e.g., with Marcaine) may be used tocomplete the surgical steps. Visual and tactile feedback of the repairshould be considered sufficient, and the procedure may then be repeatedfor other drilled locations.

According to an aspect of the present invention, the bone plate 16 maybe part of a system including components that are flexible ordeformable, such that the components can be delivered or deployed intothe body or working location in a first configuration, and then changeconfiguration, either actively or passively, into a second configurationonce inserted into the pleural space. These components may include, forexample, plates, washers, cables, wires, fasteners, or parts of thesecomponents. A deformable plate component may be longitudinally rolled,coiled, or compressed in preparation for delivery and then wholly orpartially deployed or manipulated while inside the pleural space. Thecomponents may be partially deployed so that part of the component mayassume one function while another part may serve another function. Thedeformable components may be steered, guided, or directed into a shape,location, or configuration as part of the fixation system in accordancewith the present invention.

In one embodiment, a deformable plate component 16 may be inserted whilein a first configuration, such as a rolled shape, into one drilled ribhole (FIG. 20), into the pleural space and then fed back out, across thefracture area F, and out of the pleural space through another drilledrib hole (FIG. 21). The area of the bone plate 16 between the holes onthe pleural side may then be at least partially deployed into a secondconfiguration, such as a non-round shape (FIG. 22). The end portions 17,19 of the deformable plate 16 that pass through the rib may still bemaintained in their original round shape and secured in place whileunder tension with an appropriate fastener 22, such as a unidirectionalpush lock. The ends 17, 19 of the deformable plate 16 may then betrimmed to the appropriate length.

Bone plates 16 can be additive to affect their length. For example, thebone plate 16 may be a smaller, individual portion of a modular systemof coupling or interlocking bone plates that, once inserted and placedinto general position, can be locked into final position through thetightening of fasteners 22 and 24. In one embodiment, the ends of oneplate can engage with the next plate in line, such as in an overlappedtoothed fashion, thus allowing for shaping of the plate while it isalready in the pleural space and providing for more accurate finalpositioning by the surgeon.

In one embodiment, the bone plate 16 may be made of a reinforcing meshor fabric of fibers combined with a resin matrix to form a compositereinforcing structural component or patch 44 as illustrated in FIG. 23.This patch 44 can be applied to the general area of the fracture F,extending beyond the fracture area to areas of non-fracture. Further,the patch 44 can be simultaneously applied across several spaced apartribs R at one time as shown, thus allowing for a single reinforcingmember for a multiple rib fracture site. The composite patch 44 can bejoined adhesively to the pleural side of the repair across the entiresurface, can be joined mechanically to the ribs, or a combination ofboth joining methods. The patch 44 can be supplied, while in an uncuredor otherwise pliable state, to the pleural space in one shape forinitial engagement of the bone segment, and then delivered and placedinto final position, cured, bonded, or otherwise fastened to the pleuralunderside of the ribs.

As an example of the above, a deformable patch 44 may be rolled, coiled,or compressed in preparation for delivery and then wholly or partiallydeployed or manipulated while inside the pleural space. Prior to curingor bonding to the pleura, the patch may further be steered, guided, ordirected into a shape, location, or configuration as part of thefixation system according to the present invention. The patch may bepositioned into correct placement with external manipulation via theaforementioned cables 32 or rods 36, or entirely through athorascopic-only assisted and directed placement. In the example ofthorascopic-only assisted and directed placement, a pressure applyingdevice 46, such as a balloon, can be used as part of the thorascopeassembly or in conjunction with it. As shown in FIG. 24, the pressureapplying device 46 may be used to deploy the patch 44 against thepleura, position it into a conforming shape, reduce the fractured ribsif necessary, and hold the patch 44 in that position until the patch 44is cured. In this manner, the patch 44 may either be adhesively bondedto the pleural lining and, if necessary, additionally mechanicallyattached to the ribs via the aforementioned fasteners and fasteningmethods. The pressure applying device 46 and thorascope (not shown) maythen be removed and the repair will be complete.

As a primary means of fixation or if additional fasteners are desired,they can be added through the aforementioned means. Alternatively, withthe bone plate 16 in the correct position and at least partially securedin place, additional fasteners may be placed through the bone plate 16via the inside of the chest cavity by using an internally deployeddrilling instrument that passes a drill, cable, rod or other tetheringmethod through to the external portion of the rib cage. The fastenersused via such a reversed method can be similar to those fastenersdescribed earlier. Alternatively, the fasteners can be of a blind typesuch that once the drill, cable or rod 36 is passed through the rib tothe outside with the fastener 48 housed therein for insertion (FIG. 25a), the fastener 48 can be externally pushed, internally pulled down, orotherwise deployed (FIG. 25b ) through the rib, through the bone plate16 and through the application of outward tension, engage the plate 16through the deployment of wings, hooks, arms or any other positiveengagement means with the bone plate 16 (FIGS. 26 and 27) and secured inplace by applying a counter locking mechanism, such as a push nut orthreaded nut against the external portion of the rib bone (not shown).FIG. 26 depicts a fastener 48 engaging a cable or rod type reinforcingmember 16, while FIG. 27 depicts a fastener 48 engaging a bone plate 16which includes areas 50 for receiving the fasteners 48. In anotherembodiment illustrated in FIG. 28, the bone plate 16 may have legs 52and the fastener 48 may be received and interlock between the legs 52,wherein the legs 52 may also have tabs for bone anchoring.

Any or all of the components described herein for completing the bonerepair in accordance with an aspect of the present invention can beassembled for ease of use as a surgical kit as shown in FIG. 19. A traycan be provided where the components can be conveniently and securelypositioned for ease of access and use during a surgery.

The system and method described herein allow for the rapid fixation ofbroken rib segments with minimal blood loss (e.g., a reduction of80-90%), required surgical time (e.g., a reduction of 50-75%), andreduced post-operative pain and discomfort for the patient. Disruptionof the surrounding musculature, soft tissue, cartilage, periosteum andneural structures is significantly reduced when compared to conventionalsurgical techniques. Once the surgery begins, each repair will typicallytake less than 10 minutes. This differs significantly from the currenttechniques which are quite lengthy, utilize a wide exposure, requirelarge muscle dissection and often have a complicated recovery. Patientsatisfaction with the repair should be high due to the absence ofprominent hardware, minimal post-operative recovery time and the minimalnature of the incisions.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms of the invention. Rather,the words used in the specification are words of description rather thanlimitation, and it is understood that various changes may be madewithout departing from the spirit and scope of the invention.Additionally, the features of various implementing embodiments may becombined to form further embodiments of the invention.

1-65. (canceled)
 66. A method of percutaneously fixing a first bonesegment to a second bone segment in a body of a patient, comprising:drilling a first hole through the first bone segment and a second holethrough the second bone segment; feeding a first tether through thefirst hole and a second tether through the second hole, each tetherhaving a proximal end and a distal end; withdrawing the first and secondtether distal ends from the body while the first and second tetherproximal ends have not passed through the first and second bonesegments, respectively; passing a reinforcing member onto the first andsecond tether distal ends, the reinforcing member having at least afirst opening and a second opening, wherein the reinforcing memberincludes a patch comprising a fiber mesh and resin matrix; pulling thereinforcing member into engagement with the first and second bonesegments guided by the tethers; and securing the reinforcing member tothe first bone segment and to the second bone segment to fix the firstbone segment to the second bone segment.
 67. The method of claim 66,wherein securing the reinforcing member includes adhesively joining thepatch to a pleural side of the first and second bone segments.
 68. Themethod of claim 66, further comprising deploying the patch against thebone segments using a pressure applying device.
 69. The method of claim66, wherein the first bone segment and the second bone segment are ribbone segments.
 70. The method of claim 66, further comprising making afirst percutaneous incision drilling the holes in the bone segments anda second percutaneous incision for passing the reinforcing member ontothe tether distal ends.
 71. The method of claim 66, wherein the patch issecured to the first bone segment with a first fastener assembly throughthe first hole and the first opening and to the second bone segment witha second fastener assembly through the second hole and the secondopening.
 72. The method of claim 71, wherein each tether distal end isthreaded for receiving a portion of the first or second fastenerassembly thereon.
 73. The method of claim 71, wherein the first fastenerassembly includes a first inner fastener and a first outer fastener, andthe second fastener assembly includes a second inner fastener and asecond outer fastener.
 74. The method of claim 73, wherein securing thefirst and second fastener assemblies includes feeding the first innerfastener onto the first tether distal end and the second inner fasteneronto the second tether distal end subsequent to passing the reinforcingmember, and feeding the first outer fastener onto the first tetherproximal end and feeding the second outer fastener onto the secondtether proximal end.
 75. The method of claim 73, further comprisingpulling the tether proximal ends to draw the first inner fastener intoengagement with the first outer fastener and to draw the second innerfastener into engagement with the second outer fastener.
 76. The methodof claim 66, further comprising withdrawing the first and second tethersfrom the body following securing the reinforcing member to the bonesegments.
 77. The method of claim 66, further comprising placing a stopmember on each tether distal end subsequent to feeding the reinforcingmember thereon.
 78. The method of claim 66, wherein passing thereinforcing member includes inserting the reinforcing member into thebody in a first configuration and then at least partially deploying thereinforcing member to a second configuration once inserted.
 79. Themethod of claim 66, further comprising inserting a blind fastenerthrough at least one of the first and second holes and engaging thereinforcing member by deploying positive engagement means from the blindfastener.
 80. A system for the percutaneous repair of first and secondbone segments of a fractured bone in a patient, comprising: at least afirst and second tether each having a proximal end and a distal end; areinforcing member having at least a first opening and a second opening,wherein the reinforcing member includes a patch comprising a fiber meshand resin matrix, wherein the distal end of the first tether is arrangedto be passed through the first opening and the distal end of the secondtether is arranged to be passed through the second opening; wherein thefirst and second tethers are arranged to be received through first andsecond holes in the first and second bone segments, respectively, forpulling the reinforcing member into engagement with the first and secondbone segments guided by the tethers and securing the reinforcing memberto the first bone segment and to the second bone segment to fix thefirst bone segment to the second bone segment.
 81. The system of claim80, wherein the patch includes an adhesive for joining the patch to thefirst and second bone segments.
 82. The system of claim 80, furthercomprising a first fastener assembly to secure the patch to the firstbone segment through the first hole and the first opening and a secondfastener assembly to secure the path to the second bone segment throughthe second hole and the second opening.
 83. The system of claim 82,wherein the first fastener assembly includes a first inner fastener anda first outer fastener arranged to be secured through the first hole,and the second fastener assembly includes a second inner fastener and asecond outer fastener arranged to be secured through the second hole toengage the reinforcing member with the first and second bone segments.84. The system of claim 83, wherein the first and second outer fastenerseach have a channel for passing the first and second tetherstherethrough, respectively.
 85. The system of claim 83, wherein thefirst and second tether distal ends are threaded for receiving the firstand second inner fasteners thereon, respectively.
 86. The system ofclaim 80, further comprising a stop member arranged to be received oneach tether distal end subsequent to the reinforcing member.
 87. Thesystem of claim 80, further comprising a blind fastener includingdeployable positive engagement means for engagement of the reinforcingmember.
 88. The system of claim 80, wherein the first and second bonesegments comprise rib bone segments.
 89. A kit for surgical repair of afractured bone involving a first bone segment and a second bone segment,comprising: a hollow trocar for engaging the first and second bonesegments; a drill guide arranged to be received through the trocar forfacilitating drilling of a first hole in the first bone segment and asecond hole in the second bone segment; at least a first and secondtether each having a proximal end and a distal end; at least onereinforcing member having at least a first opening and a second opening,wherein the reinforcing member includes a patch comprising a fiber meshand resin matrix, wherein the distal end of the first tether is arrangedto be passed through the first opening and the distal end of the secondtether is arranged to be passed through the second opening; wherein thefirst and second tethers are arranged to be received through the firstand second holes in the first and second bone segments, respectively,for pulling the reinforcing member into engagement with the first andsecond bone segments guided by the tethers and securing the reinforcingmember to the first bone segment and to the second bone segment to fixthe first bone segment to the second bone segment.
 90. The kit of claim89, wherein the patch includes an adhesive for joining the patch to thefirst and second bone segments.
 91. The kit of claim 89, furthercomprising a first fastener assembly to secure the patch to the firstbone segment through the first hole and the first opening and a secondfastener assembly to secure the patch to the second bone segment throughthe second hole and the second opening.
 92. The kit of claim 91, whereinthe first fastener assembly includes a first inner fastener and a firstouter fastener arranged to be secured through the first hole, and thesecond fastener assembly includes a second inner fastener and a secondouter fastener arranged to be secured through the second hole to engagethe reinforcing member with the first and second bone segments.
 93. Thekit of claim 92, wherein the first and second outer fasteners each havea channel for passing the first and second tethers therethrough,respectively.
 94. The kit of claim 92, wherein the first and secondtether distal ends are threaded for receiving the first and second innerfasteners thereon, respectively.
 95. The kit of claim 92, furthercomprising a drive tool arranged to be received through the trocar forsecuring the outer fasteners to the inner fasteners.
 96. The kit ofclaim 92, further comprising at least two stop members to be placed oneach tether distal end for retaining the reinforcing member and innerfasteners on the tethers.
 97. The kit of claim 89, further comprising ablind fastener including deployable positive engagement means forengagement of the reinforcing member.
 98. The kit of claim 89, whereinthe first and second bone segments comprise rib bone segments.